Formula #1000-b-bulk Gel - 70% Ethyl Alcohol Hand Sanitizer

SPL v5

SPL

SPL Set ID 6e013ae7-955c-9d9c-e053-2991aa0a2767

Route

TOPICAL

Published

Effective Date 2020-04-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (20.4 mL)

Inactive Ingredients

Trolamine Carbomer 1342 Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2012-08-01

Description

Ethyl Alcohol 70% v/v

Indications and Usage

Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

Purpose... Antiseptic

Dosage and Administration

Directions : Wet hands thoroughly with product and allow to dry without wiping.

Medication Information

Indications and Usage

Use Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Purpose

Purpose... Antiseptic

Dosage and Administration

Directions: Wet hands thoroughly with product and allow to dry without wiping.

Description

Ethyl Alcohol 70% v/v

Section 50741-8

Flammable: Keep away from open flame.

Avoid freezing and excessive heat above 40C (104F).

Section 60561-8

Other information: Non-staining, may discolor certain fabrics.

Warning

WARNINGS: For external use only

When using this product avoid contact with eyes. If contact with eyes occurs, flush with water.

Stop use and ask a doctor if irritation or redness develops and persists. If swallowed, seek prompt medical attention.

Otc Purpose

Purpose... Antiseptic

Use: Updated

Use Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Active Ingredient

Ethyl Alcohol 70% v/v

Inactive Ingredient

InActive Ingredients: Water, Carbomer, Triethanolamine

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, seek prompt medical attention.

Package Label Principal Display Panel

Structured Label Content

Section 50741-8 (50741-8)

Flammable: Keep away from open flame.

Avoid freezing and excessive heat above 40C (104F).

Section 60561-8 (60561-8)

Other information: Non-staining, may discolor certain fabrics.

Warning (WARNING)

WARNINGS: For external use only

When using this product avoid contact with eyes. If contact with eyes occurs, flush with water.

Stop use and ask a doctor if irritation or redness develops and persists. If swallowed, seek prompt medical attention.

Otc Purpose (OTC PURPOSE)

Purpose... Antiseptic

Use: Updated (Use: updated)

Use Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Active Ingredient (ACTIVE INGREDIENT)

Ethyl Alcohol 70% v/v

Inactive Ingredient (INACTIVE INGREDIENT)

InActive Ingredients: Water, Carbomer, Triethanolamine

Indications and Usage (INDICATIONS AND USAGE)

Use Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Directions: Wet hands thoroughly with product and allow to dry without wiping.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children. If swallowed, seek prompt medical attention.

Package Label Principal Display Panel (PACKAGE LABEL PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

[{"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "20.4", "strengthDenominator": "30", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER 1342", "unii": "809Y72KV36", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"50741-8": "Flammable: Keep away from open flame. Avoid freezing and excessive heat above 40C (104F).", "60561-8": "Other information: Non-staining, may discolor certain fabrics.", "WARNING": "WARNINGS: For external use only When using this product avoid contact with eyes. If contact with eyes occurs, flush with water. Stop use and ask a doctor if irritation or redness develops and persists. If swallowed, seek prompt medical attention.", "OTC PURPOSE": "Purpose... Antiseptic", "Use: updated": "Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "ACTIVE INGREDIENT": "Ethyl Alcohol 70% v/v", "INACTIVE INGREDIENT": "InActive Ingredients: Water, Carbomer, Triethanolamine", "INDICATIONS AND USAGE": "Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "DOSAGE AND ADMINISTRATION": "Directions : Wet hands thoroughly with product and allow to dry without wiping.", "KEEP OUT OF REACH OF CHILDREN": "Keep out of reach of children. If swallowed, seek prompt medical attention."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:12.631125 · Updated: 2026-03-14T22:57:39.571374